Medical Devices Recalls

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.

Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

The failure to detect the partial obstruction in a 2.5mm sensor.

Patient support table floor plate may be incorrectly installed.

The failure to detect the partial obstruction in a 2.5mm sensor.

Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.